China In 2019: Coming Regulatory Changes To Keep On Your Radar
From heightened overseas manufacturing inspections to a new patent challenge mechanism, important regulatory changes are coming in China this year, and implementation could potentially derail your operations in this key market.
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An officially released new regulation in China legalizes overseas inspections of drug and device makers, making the risk-based inspections routine tasks that could also expand to manufacturers' R&D partners and third-party suppliers of ingredients, excipients or packaging materials.
Amid a global uproar denouncing a Chinese scientist’s work to deliver gene-edited twin babies, worries emerge that other valuable future research in the area could be put on hold, effectively crippling industry experts and researchers.
The first vaccine for the new coronavirus has entered the clinic, with US firm Moderna leading the race.